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    Clinical Research Director, I&I - Cambridge, United States - Taleo BE

    Taleo BE
    Taleo BE Cambridge, United States

    2 weeks ago

    Default job background
    Description
    Clinical Research Director - allergy-immunology-dermatology
    The Clinical Research Director (CRD) is noted as the

    primary clinical expert for programs .


    The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.


    Key responsibilities include:
    Participate/support clinical program lead in the clinical development plan strategies:
    Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
    Raise study issues to the clinical lead
    Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
    Evaluates relevant medical literature and status from competitive products

    Lead, Support and oversee the execution of clinical development and studies activities
    Review and validate the final protocol and protocol amendments
    Review the ICF WSI and TDF
    Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
    Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support
    Co-Develop the SAP in collaboration with bio stats
    Responsible for key results preparation
    Develop the clinical study report

    Take on as necessary the Associate CRD role:
    Develop the abbreviated protocol
    Develop the final protocol and protocol amendments
    Medical support to clinical operation team during the clinical feasibility
    Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
    Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
    Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
    Participate in the elaboration of training material and presentations at the investigator meetings
    Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ...) with operational support, bio stat and GSO
    Answer to medical questions raised by EC/IRBs, sites
    Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
    Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:

    feasibility managers for feasibility preparation and validation of feasibility results
    Medical Writers to develop, review and finalize WSIs, study protocols and reports
    Clinical Scientists, Medical review team and Coding
    Pharmacovigilance (GSO, CME)
    CTOMs, Biostatisticians
    CSU medical advisors for the best knowledge of the study, compound, protocol
    TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs
    CROs
    Regulatory affairs


    Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams.

    He/she raises study or project-level issues to the global project head and clinical lead
    Provide operational expertise to project clinical sub team, as needed

    Responsibilities related to regulatory and safety documents and meetings:
    Review and/or contribute in the the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
    Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities

    Ensures clinical data meets all necessary regulatory standards
    Participates in Advisory Committee preparation

    Scientific Data evaluation and authorship:
    Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

    Experience
    Robust Scientific and medical/clinical expertise
    Expertise in clinical development and methodology of clinical studies
    Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
    Demonstrated capability to challenge decision and status quo with a risk-management approach
    Ability to negotiate to ensure operational resources are available for continued clinical conduct
    Fluency in written and spoken English
    Very good teaching skills, demonstrated ability to assist and train others
    Ability to work within a matrix model
    International/ intercultural working skills
    Open-minded to apply new digital solutions

    Minimum Level of any Required Qualifications:
    Medical Doctor (MD): trained in allergy and/or immunology and/or dermatology
    English fluent (spoken and written)
    Experience in clinical trials (industry or academia as PI)
    Computer skills

    Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.

    All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

    #GD-SA
    #LI-SA

    Pursue

    progress , discover

    extraordinary

    Better is out there. Better medications, better outcomes, better science.

    But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing:
    a desire to make miracles happen. So, let's be those people.


    At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

    Watch our

    ALL IN video

    and check out our Diversity Equity and Inclusion actions at

    #J-18808-Ljbffr
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